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Recall Observatory FDA recall evidence

Device product

RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.

Z-0532-2024

September 06, 2023

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 93428
Status
Ongoing
Classification
Class II
Quantity
146 units
Official record key
device-enforcement:Z-0532-2024

Official wording

Reason: Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver

Code information: Part Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825, 769P2846, 769P2893

Distribution pattern: U.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX, VA, and WA O.U.S.: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver